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US Gene Patents – Further Progress in the Myriad Gene Case

We have previously reported on the progress of the “Myriad Gene Case”. A suit was brought against Myriad by a number of parties, including the Association of Molecular Pathology, in which the validity of a number of patents owned by Myriad relating to isolated sequences of DNA was challenged.

The patents claimed isolated DNA fragments that encoded for the BRCA1 and BRCA2 proteins, certain mutations of which have been linked to an increased likelihood of developing breast and ovarian cancer. In March 2010, the District Court ruled that claims relating to isolated genes in seven of Myriad’s patents were invalid, as isolated genes were classed as products of nature and so were excluded from patentability.

Myriad appealed this decision to the Federal Circuit, who heard oral arguments from both sides in April 2011. The Federal Circuit have now issued their decision, reversing the decision of the District Court insofar as it relates to claims to isolated genes, but upholding the decision to reject certain of the method claims relating to the genes.

In their arguments, Myriad had asserted that an isolated DNA molecule is not a naturally occurring composition of matter, but has a distinctive name, character and use. As it does not exist in nature, it could not be considered to be a product of nature and therefore is not excluded from patentability.

On the other side, the argument centred around an assertion that, because isolated DNA retains the same nucleotide sequence as native DNA, it does not have any markedly different characteristics which could make it patentable. It therefore falls under the category of “natural phenomena and products of nature”, and is ineligible for patentability.

In their decision, the Federal Circuit spent some time considering the difference between a product of nature and a man-made invention, stating that the distinction turns on whether there has been a change in the identity of the product compared with what exists in nature. They looked at the chemical and structural differences between native DNA and isolated DNA, and considered that isolated DNA is cleaved from the native chromosomal segments on either side of it, lacks histone complexes present in native DNA, and may also include only coding portions of the gene or exons.

Hence, the Federal Circuit concluded that the isolated DNA molecules have a distinctive chemical identity and nature from DNA in its natural state.

Judge Lourie, speaking for the Federal Circuit, stated that isolated DNA is not simply purified DNA. Purification implies that making pure something that was previously impure. However, DNA does not exist in nature within a mixture to be purified. Isolated DNA has to be chemically cleaved from other genetic materials; thus, it is a distinct chemical entity.

The judge went on to say that, contrary to some of the arguments, it is not relevant to patentability whether the nature of the genetic information is the same in natural and isolated DNA. This fact may be relevant to the determination of inventive step, but it does not in itself exclude a product from patentability.

One of the other judges involved, Judge Moore, additionally considered the issue of patentability of isolated DNA in view of the long standing practice of the USPTO to grant claims to such subject matter. She considered that cDNA and short fragments of isolated genomic DNA have markedly different characteristics to a native DNA molecule which may contain 80 million nucleotides, but that the patentability of claims encompassing the isolated full length gene was harder to determine. When concluding that they should be considered patentable subject matter, she stated that “we must be particularly wary of expanding the judicial exception to patentable subject matter where both settled expectations and extensive property rights are involved…these settled expectations tip the scale in favour of patentability”.

The outcome of this case is of particular interest to those involved in the biotech industries who own US patents covering isolated genes. The decision of the Federal Circuit has maintained the status quo, stating that isolated genes are patentable subject matter. However, it is likely that the decision will be appealed to the Supreme Court.



12 September 2011

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